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Treatment of primary hypercholesterolaemia. Short‐term efficacy and safety of increasing doses of simvastatin and pravastatin: a double‐blind comparative study
Author(s) -
STALENHOEF A. F. H.,
LANSBERG P. J.,
KROON A. A.,
KORTMANN B.,
HAAN A. F. J.,
STUYT P. M. J.,
KASTELEIN J. J. P.
Publication year - 1993
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1111/j.1365-2796.1993.tb00708.x
Subject(s) - pravastatin , simvastatin , medicine , apolipoprotein b , cholesterol , endocrinology , lipoprotein , adverse effect , hydroxymethylglutaryl coa reductase , hmg coa reductase , reductase , biochemistry , enzyme , chemistry
. Objectives . To compare the efficacy and safety of increasing doses (0, 10, 20 and 40 mg day −1 , each dose for 6 weeks) of the inhibitors of 3‐hydroxy‐3‐methylglutaryl coenzyme A reductase, simvastatin and pravastatin, in the treatment of primary hypercholesterolaemia. Design . Randomized, double‐blind study with two parallel groups. Setting . Two specialist lipid clinics in the Netherlands. Subjects . Forty‐eight patients aged 25–66 years with primary hypercholesterolaemia (mean serum cholesterol 10.2 mmol −1 ). Main outcome measures . Total serum cholesterol, triglycerides, lipoproteins, apolipoproteins A‐I and B, laboratory safety parameters and sleep questionnaires. Results . Both drugs induced a dose‐dependent reduction in the mean total and low‐density lipoprotein cholesterol concentration ( P < 0.001); low‐density lipoprotein cholesterol decreased from 32 to 43% by simvastatin and from 23 to 33% by pravastatin. There was an overall difference in the mean relative change from baseline in favour of simvastatin (total cholesterol, P < 0.01; LDL cholesterol P < 0.001). Both drugs reduced serum triglycerides by 10–15%. The changes in apolipoprotein B and the differences in efficacy between the two drugs paralleled those of total and low‐density lipoprotein cholesterol. Adverse experiences were mild and did not differ between treatment groups; in each group, one subject discontinued medication because of complaints of dizziness. Sleep questionnaires revealed different degrees of sleep problems, unaffected by active treatment. Conclusions . Simvastatin appeared to be more potent than pravastatin in lowering total cholesterol, low‐density lipoprotein cholesterol and apolipoprotein B, whereas both drugs had the same short‐term safety profile.